ABRAXANE and Advanced Breast Cancer

What should I know about
metastatic breast cancer?

Most common places in the body where MBC may spread.

What is metastatic breast cancer?

Breast cancer is a tumor (TOO-mer) that starts in the breast. A tumor is an abnormal mass of tissue. When a tumor is malignant (muh-LIG-nuhnt), it means that it is cancerous.
When breast cancer spreads from the breast to other parts of the body, it is called metastatic (met-tuh-STA-tik) breast cancer (MBC). This type of cancer is also called advanced or stage 4 breast cancer.

Most common places in the body where MBC may spread.

How many people have metastatic
breast cancer?

If you have MBC, you are not alone:

More than 155,000 people in the United States are living with MBC

231,840 new cases of breast cancer are predicted in 2015

30% of women originally diagnosed with early stage breast cancer are estimated to become advanced or metastatic at some point in their lives

About 5% of people with breast cancer will be diagnosed with MBC from the start rather than after an early stage diagnosis

Are some people more at risk for breast cancer?

There are certain factors that affect a person’s chance of getting breast cancer. It is important to know that having 1 or more risk factors does not mean that you will definitely get breast cancer. And some people may get this type of cancer even if they don’t have any risk factors.

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Age

Your risk of breast cancer increases as you get older. About 2 out of 3 invasive (in-VEY-siv) breast cancers are found in women aged 55 or older. These are cancers that grow into (invade) normal tissues in or beyond the breast.

Gender

Women are much more likely than men to get breast cancer. It’s 100 times more common in women than men, but it is possible in either gender.

Race

Breast cancer is slightly more common in Caucasian women than in African American women. But African American women are more likely to die of this type of cancer. In younger women (under 45 years of age), breast cancer is more common in African American women. Asian, Hispanic, and Native American women have a lower risk of breast cancer.

Personal or Family History

A woman who has had cancer in one breast is more likely to get a new cancer in the other breast or in another part of the same breast. Women who have a close blood relative with breast cancer are also at greater risk.

Genes

About 5% to 10% of cases are thought to be hereditary (huh-RED-i-ter-ee). This means that the cancer is caused by genetic defects, called mutations (myoo-TEY-shuhns), that are passed on from a parent.

In addition to a person’s age, gender, race, and family history—all things that can’t be changed—there are risk factors for breast cancer that are considered lifestyle factors. This means that they can be controlled to some degree.

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Drinking Alcohol

Compared with nondrinkers, women who have 1 alcoholic drink a day have a slightly higher risk of breast cancer. Women who have 2 to 5 drinks a day have a greater risk.

Weight

Women who are overweight or obese after menopause are at greater risk for breast cancer.

Having Children

Women who have not had children or who had their first child after age 30 are at a slightly higher risk for breast cancer.

Birth Control

Certain forms of birth control put women at greater risk of breast cancer. These include birth control pills and an injectable form of the hormone progesterone that’s given once every 3 months.

Hormone Therapy

Women who take a combination of estrogen and progesterone after menopause to help ease symptoms or prevent osteoporosis (thinning of the bones) are at higher risk for breast cancer.

What is ABRAXANE?

ABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer.
ABRAXANE is a chemotherapy (KEE-moh-THAYR-uh-pee). Chemotherapy is a type of medicine that is used to keep cancer cells from growing or to kill cancer cells. Treatment with ABRAXANE may help control or slow the spread of cancer cells.
Your doctor may recommend treatment with ABRAXANE based on the stage of your cancer, your response to prior therapy, and your overall health. Only your doctor can help you decide if ABRAXANE is right for you.

What is in ABRAXANE?

The medicine in ABRAXANE, paclitaxel, is bound to albumin.Illustrative purposes only.

ABRAXANE is a different formulation of the cancer-fighting medicine paclitaxel (PAK-li-TAK-sel). ABRAXANE is made by binding paclitaxel to albumin (al-BYOO-min). Albumin is a protein found in the blood.

The medicine in ABRAXANE, paclitaxel, is bound to albumin. Illustrative purposes only.

Here is what this means to you:

Because ABRAXANE is bound to albumin, no solvents are needed to dissolve it

Solvents are chemicals that dissolve some medicines so that they can be given by infusion(in-FYOO-zhun)

Some solvents can cause allergic reactions

Since ABRAXANE does not contain solvents, it is not usually necessary to take medicines to prevent allergic reactions before ABRAXANE is given. These medicines are called premedication

It is important to know that allergic reactions can occur with ABRAXANE. Premedication may be needed if you have had an allergic reaction. Allergic reactions may be severe and can lead to death. In case of severe allergic reaction, ABRAXANE should not be used again.

How does ABRAXANE work?

ABRAXANE travels through the bloodstream to reach cells in many parts of the body, including cancer cells.Illustrative purposes only.

ABRAXANE may help stop cancer cells from dividing and making new cells. ABRAXANE works by blocking the action of proteins called microtubules (MY-kroh-TOO-byools).These proteins help cells divide.Systemic (sis-TEH-mik) treatments like ABRAXANE are used to treat metastatic (meh-tuh-STA-tik) cancer. This is cancer that has spread from one part of the body to another. It is also known as advanced or stage 4 cancer. Systemic treatments travel through the bloodstream. This makes it possible to reach cells in many parts of the body, including cancer cells. ABRAXANE may also affect normal cells. This may cause side effects.

ABRAXANE travels through the bloodstream to reach cells in many parts of the body, including cancer cells.Illustrative purposes only.

How is ABRAXANE given?

ABRAXANE is given by intravenous (IN-truh-VEE-nus), or IV, infusion(in-FYOO-zhun).
To begin the infusion:

A nurse inserts a thin, soft tube into your vein to give the medicine. This is often called an IV. If you have a central line in place, the nurse will use that to give you the medicine

ABRAXANE flows through the IV into your bloodstream

After each infusion, the nurse removes the IV or the device that delivered the medicines through your central line. Your central line or port stays in place

Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). You should be monitored by your doctor or nurse during and after you receive ABRAXANE to make sure no problems occur at the injection site. In some cases, these problems occurred 7 to 10 days after the medicine was injected.
Your treatment with ABRAXANE will be given in your doctor’s office, at a hospital, or at an infusion center. Each infusion of ABRAXANE takes 30 minutes. Tests, checkups, or waiting time may affect the length of treatment sessions.

How often will I be given ABRAXANE?

ABRAXANE is given once every 3 weeks. If you have questions about your treatment schedule, ask your doctor.

ABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

ABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer.

Important Safety Information

WARNING – LOW WHITE BLOOD CELL COUNT (NEUTROPENIA)

Do not take ABRAXANE if your white blood cell count is below 1500 cells/mm3 (neutropenia), since you may be more likely to get a serious infection. While taking ABRAXANE, you must get regular blood tests to check for any problems that could develop

ABRAXANE contains albumin, a substance found in human blood. Do not substitute for or with other paclitaxel formulations

Who Should Not Receive ABRAXANE?

Do not receive ABRAXANE if:

your white blood cell count is below 1500 cells/mm3

you have had a severe allergic reaction to ABRAXANE

Serious Side Effects

ABRAXANE may cause serious side effects, including:

decreased blood counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cell important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment

numbness, tingling, pain, or weakness in the hands or feet (neuropathy)

allergic (hypersensitivity) reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE

Other Risks

Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered or withheld

ABRAXANE contains albumin (human), a product of human blood

Risks to Pregnancy

If you are pregnant or become pregnant, ABRAXANE can harm your unborn baby. You should not become pregnant while taking ABRAXANE. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving ABRAXANE

If you are a man, you should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner

In some patients receiving ABRAXANE, severe heart and blood vessel side effects have occurred. These included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, high blood pressure, stroke, and heart failure

Other Important Safety Information about ABRAXANE

You should contact your doctor if you have signs or symptoms of vomiting, diarrhea, dehydration, cough, or breathing difficulties that do not go away, or signs of an allergic reaction. Tell your doctor if you have any other medical conditions

Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). You should be monitored by your doctor or nurse during and after you receive ABRAXANE to make sure no problems occur at the injection site. In some cases, these problems occurred 7 to 10 days after the medicine was injected

It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking

Since it is not known if ABRAXANE passes into human milk, you should discuss with your doctor if you should receive ABRAXANE or breastfeed

It is not known if ABRAXANE is safe or effective in children

ABRAXANE has not been adequately studied in people with severe kidney problems

These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Important Safety Information

ABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer.

Important Safety Information

WARNING – LOW WHITE BLOOD CELL COUNT (NEUTROPENIA)

Do not take ABRAXANE if your white blood cell count is below 1500 cells/mm3 (neutropenia), since you may be more likely to get a serious infection. While taking ABRAXANE, you must get regular blood tests to check for any problems that could develop

ABRAXANE contains albumin, a substance found in human blood. Do not substitute for or with other paclitaxel formulations

Who Should Not Receive ABRAXANE?

Do not receive ABRAXANE if:

your white blood cell count is below 1500 cells/mm3

you have had a severe allergic reaction to ABRAXANE

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Serious Side Effects

ABRAXANE may cause serious side effects, including:

decreased blood counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cell important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment

numbness, tingling, pain, or weakness in the hands or feet (neuropathy)

allergic (hypersensitivity) reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE

Other Risks

Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered or withheld

ABRAXANE contains albumin (human), a product of human blood

Risks to Pregnancy

If you are pregnant or become pregnant, ABRAXANE can harm your unborn baby. You should not become pregnant while taking ABRAXANE. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving ABRAXANE

If you are a man, you should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner

In some patients receiving ABRAXANE, severe heart and blood vessel side effects have occurred. These included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, high blood pressure, stroke, and heart failure

Other Important Safety Information about ABRAXANE

You should contact your doctor if you have signs or symptoms of vomiting, diarrhea, dehydration, cough, or breathing difficulties that do not go away, or signs of an allergic reaction. Tell your doctor if you have any other medical conditions

Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). You should be monitored by your doctor or nurse during and after you receive ABRAXANE to make sure no problems occur at the injection site. In some cases, these problems occurred 7 to 10 days after the medicine was injected

It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking

Since it is not known if ABRAXANE passes into human milk, you should discuss with your doctor if you should receive ABRAXANE or breastfeed

It is not known if ABRAXANE is safe or effective in children

ABRAXANE has not been adequately studied in people with severe kidney problems

These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.

ABRAXANE is a prescription medicine used to treat advanced breast cancer in people who have already received certain other medicines for their cancer.

Important Safety Information

WARNING – LOW WHITE BLOOD CELL COUNT (NEUTROPENIA)

Do not take ABRAXANE if your white blood cell count is below 1500 cells/mm3 (neutropenia), since you may be more likely to get a serious infection. While taking ABRAXANE, you must get regular blood tests to check for any problems that could develop

ABRAXANE contains albumin, a substance found in human blood. Do not substitute for or with other paclitaxel formulations

Who Should Not Receive ABRAXANE?

Do not receive ABRAXANE if:

your white blood cell count is below 1500 cells/mm3

you have had a severe allergic reaction to ABRAXANE

Serious Side Effects

ABRAXANE may cause serious side effects, including:

decreased blood counts. ABRAXANE can cause a severe decrease in neutrophils (a type of white blood cell important in fighting against bacterial infections) and platelets (important for clotting and to control bleeding). Your doctor will check your blood cell count during your treatment with ABRAXANE and after you have stopped your treatment

numbness, tingling, pain, or weakness in the hands or feet (neuropathy)

allergic (hypersensitivity) reactions, which could be severe and sometimes fatal, have been reported with ABRAXANE

Other Risks

Treatment with ABRAXANE can make liver problems worse. If you have liver problems, your starting dose of ABRAXANE should be lowered or withheld

ABRAXANE contains albumin (human), a product of human blood

Risks to Pregnancy

If you are pregnant or become pregnant, ABRAXANE can harm your unborn baby. You should not become pregnant while taking ABRAXANE. Women who may become pregnant should use effective birth control (contraception). Talk to your doctor about the best way to prevent pregnancy while receiving ABRAXANE

If you are a man, you should not father a child during your treatment with ABRAXANE. ABRAXANE can harm the unborn baby of your partner

In some patients receiving ABRAXANE, severe heart and blood vessel side effects have occurred. These included chest pain, heart attack, fluid under the skin, blood clots in the veins or lungs, high blood pressure, stroke, and heart failure

Other Important Safety Information about ABRAXANE

You should contact your doctor if you have signs or symptoms of vomiting, diarrhea, dehydration, cough, or breathing difficulties that do not go away, or signs of an allergic reaction. Tell your doctor if you have any other medical conditions

Treatment with ABRAXANE can cause irritation where the medicine is injected (injection site reactions). You should be monitored by your doctor or nurse during and after you receive ABRAXANE to make sure no problems occur at the injection site. In some cases, these problems occurred 7 to 10 days after the medicine was injected

It is not known whether ABRAXANE interacts with other drugs, so be sure to tell your doctor about any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements you are taking

Since it is not known if ABRAXANE passes into human milk, you should discuss with your doctor if you should receive ABRAXANE or breastfeed

It is not known if ABRAXANE is safe or effective in children

ABRAXANE has not been adequately studied in people with severe kidney problems

These are not all the possible side effects of ABRAXANE. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Glossary

What do all these terms mean?

Facing the challenge of advanced cancer can be hard enough without the confusion of medical terms. It is important that you understand the language of cancer so that you can take an active role in your treatment. Always ask your healthcare team to explain things simply if there is something you don’t understand.

Advanced cancer

Cancer that has spread to other places in the body.

Albumin (al-BYOO-min)

A type of protein found in the blood.

Anemia (uh-NEE-mee-uh)

A condition in which the number of red blood cells is below normal. Red blood cells carry oxygen to your body tissues. Anemia can make you feel tired, weak, and short of breath.

Blood cell count

The number of red blood cells, white blood cells, and platelets in a sample of blood.

Carboplatin (KAR-boh-pla-tin)

A chemotherapy medicine prescribed to treat cancer. It can be used alone or with other chemotherapies.

Chemotherapy (KEE-moh-THAYR-uh-pee)

Medicines used to keep cancer cells from growing or to kill cancer cells.

Colloidal (kuh-LOY-dul) oatmeal

Fine powder made from ground oats added to bath water to soothe dry, itchy skin.

Dehydration (dee-hy-DRAY-shun)

Loss of too much water and needed fluids from the body. May be caused by vomiting, diarrhea, or fever.

Gemcitabine (jem-CY-tuh-been)

A chemotherapy medicine prescribed to treat cancer. It can be used alone or with other chemotherapies.

Hereditary (huh-RED-i-ter-ee)

A term for a condition that is passed through the genes from parent to offspring.

Infusion (in-FYOO-zhun)

A way of giving medicine that allows it to pass directly into the bloodstream. Also called intravenous (IN-truh-VEE-nus), or IV, infusion.

Invasive (in-VEY-siv) cancer

Cancer that grows into (invades) normal tissues in or beyond where it began.

Malignant (muh-LIG-nuhnt) tumor

A tumor that invades and destroys nearby tissue and may spread to other parts of the body.

Metastatic (meh-tuh-STA-tik)

Cancer that has spread from one part of the body to another. Also known as advanced or stage 4 cancer.

Microtubules (MY-kroh-TOO-byools)

Proteins that help cells divide.

Mutation (myoo-TEY-shuhn)

A defect in the genes.

Neuropathy (nor-AH-puh-thee)

Numbness, tingling, pain, or weakness in the hands or feet that may be caused by chemotherapy, injury, infection, or conditions such as diabetes or kidney failure. Also known as peripheral (peh-RIH-feh-rul) neuropathy.

Neutropenia (noo-troh-PEE-nee-uh)

A condition in which the number of neutrophils is below normal.

Neutrophils (NOO-troh-fils)

A type of white blood cell that helps fight infection.

Paclitaxel (PAK-li-TAK-sel)

A medicine used to treat cancer.

Pancreas (PAN-kree-uhs)

An organ found behind your stomach that helps the body digest food and provides energy for the body’s activities.

Platelet (PLAYT-let)

A type of cell found in the blood that helps slow or stop bleeding.

Sepsis (SEP-sis)

The presence of bacteria or toxins in the blood or tissues.

Solvents

Chemicals that help dissolve a medicine so that it can be given by infusion.

Systemic therapy (sis-TEH-mik THAYR-uh-pee)

Medicines that travel through the bloodstream to reach cells in many parts of the body.

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